Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Emergo). ARTG record, intended purpose,…

Intended purpose

The MassTrak™ Endocrine Product Family is designed to be used in a clinical biochemistry laboratory by trained professionals for the quantitative determination of steroids to aid with monitoring of physiological markers. The primary users of the Endocrinology Products will be clinical laboratory technicians who are trained and qualified for the safe handling of human biological samples and operation of an LC-MS/MS system.

TGA Public Summary